Study to assess efficacy, safety, and tolerability of oral tropifexor (LJN452) & licogliflozin (LIK066) combination therapy, and each monotherapy, compared with placebo (ELIVATE)

A randomized, double-blind, parallel-group, multicenter study to assess efficacy, safety, and tolerability of oral tropifexor (LJN452) & licogliflozin (LIK066) combination therapy and each monotherapy, compared with placebo for treatment of adult participants with nonalcoholic steatohepatitis (NASH) and liver fibrosis (ELIVATE) - ELIVATE

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080225078

Enrollment

380

Registered

2020-02-18

Start date

2020-03-02

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

nonalcoholic steatohepatitis

Interventions

investigational material(s) Generic name etc : INN of investigational material : tropifexor+licogliflozin Therapeutic category code : 391 Agents for liver disease Dosage and Administration for Invest

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Presence of NASH with fibrosis confirmed by central reader's evaluation of liver biopsy obtained no more than 6 months before randomization as demonstrated by the following: 1.NASH using NAFLD Activity Score (NAS) >= 4 with at least 1 point each in inflammation and ballooning and 2.Fibrosis stage 2 or 3 using NASH CRN fibrosis criteria

Exclusion criteria

Exclusion criteria: - Type 1 diabetes mellitus - Uncontrolled type 2 diavetes defined as blycated hemoglobin(HbA1c) >= 9.0% at screening - HbA1c ULN (see Central laboratory manual). - ALT or AST > 5xULN(confirmed by 2 values during screening). - Total billirubin > ULN(see Central laboratory manual)(confirmed by 2 values during screening), including Gilbert's syndrome. - Alkaline phosphatase > 300 IU/L (confirmed by 2 values during screening). - History of esophageal varices, ascites or hepatic encephalopathy - Splenomegaly - MELD score > 12

Design outcomes

Primary

Measure	Time frame
efficacy - Whether the participant achieves at least one stage of improvement in fibrosis without worsening of NASH (YES/NO) [ Time Frame: 48 weeks ] - Whether the participant has resolution of NASH without worsening of fibrosis (YES/NO) [ Time Frame: 48 weeks ]	—

Secondary

Measure	Time frame
efficacy - Whether the participant achieves resolution of NASH and no worsening of fibrosis OR improvement in fibrosis by at least one stage without worsening of NASH (YES/NO) [ Time Frame: 48 weeks ] - Whether the participant has at least one stage improvement in fibrosis (YES/NO) [ Time Frame: 48 weeks ] - Whether the participant has at least two stage improvement in fibrosis without worsening of NASH (YES/NO) [ Time Frame: 48 weeks ] - Whether the participant has 5% or more reduction in body weight (YES/NO) [ Time Frame: 48 weeks ] - Change in liver fat content based on MRI - PDFF (in 40% of participants) [ Time Frame: 48 weeks ] - Change in ALT and AST over time [ Time Frame: 48 weeks ] - Change in GGT over time [ Time Frame: 48 weeks ] - Occurrence of adverse events, serious adverse events, adverse events resulting in discontinuation of study treatment, adverse events of special interest and changes in vital signs and laboratory parameters [ Time Frame: 48 weeks ]	—

Measure

Time frame

efficacy - Whether the participant achieves resolution of NASH and no worsening of fibrosis OR improvement in fibrosis by at least one stage without worsening of NASH (YES/NO) [ Time Frame: 48 weeks ] - Whether the participant has at least one stage improvement in fibrosis (YES/NO) [ Time Frame: 48 weeks ] - Whether the participant has at least two stage improvement in fibrosis without worsening of NASH (YES/NO) [ Time Frame: 48 weeks ] - Whether the participant has 5% or more reduction in body weight (YES/NO) [ Time Frame: 48 weeks ] - Change in liver fat content based on MRI - PDFF (in 40% of participants) [ Time Frame: 48 weeks ] - Change in ALT and AST over time [ Time Frame: 48 weeks ] - Change in GGT over time [ Time Frame: 48 weeks ] - Occurrence of adverse events, serious adverse events, adverse events resulting in discontinuation of study treatment, adverse events of special interest and changes in vital signs and laboratory parameters [ Time Frame: 48 weeks ]

—

Countries

Africa, Asia except Japan, Japan, North America, South America

Contacts

Public ContactHiroyuki Yamada

Novartis Pharma. K.K.

rinshoshiken.toroku@novartis.com+81-120-003-293

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026